Topical Analgesia Using Electrical and Vibration Stimuli

ABSTRACT

Various embodiments disclosed herein relate to a device having a base and a stimulation module that can be attached to a patient&#39;s skin and actuated to mask the pain caused when sharp objects penetrate the skin. The stimulation module is designed to generate vibration energy, or alternatively, is designed to generate both vibration and electrical energy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/091,753, filed Apr. 21, 2011 and entitled “Topical Analgesia UsingElectrical and Vibration Stimuli,” which claims the benefit under 35U.S.C. §119(e) to U.S. Provisional Application 61/327,491, filed Apr.23, 2010 and entitled “Topical Analgesia Using Electrical and VibrationStimuli,” both of which are hereby incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

Various embodiments disclosed herein relate to methods and devices forreducing or eliminating the pain from injections and other similarprocedures performed on skin by the application of transcutaneouselectrical nerve stimulation (“TENS”) and/or vibration stimulation. Morespecifically, the various embodiments relate to an adhesive skin patchand a coupleable stimulation unit used to deliver TENS or vibration orboth to the patient.

BACKGROUND OF THE INVENTION

Injections and other procedures requiring the piercing of the skin havebeen a necessary part of medical treatment for humans and animals forcenturies. Painful injections into and through the skin forimmunizations, medication administration, blood sugar testing,phlebotomy, IV placement, and the like, are usually done without the useof a local or topical anesthetic. This results in an unpleasantexperience for most adults, and may be an extremely traumatic event forchildren or other sensitive persons.

At times, the fear or aversion to these types of procedures may lead tononcompliance of treatments and testing by adults and children alike.Products to reduce the pain of injections and similar procedures doexist but have significant drawbacks and are not used often because ofthese limitations.

There is a need in the art for improved systems, methods, and devicesfor reducing or eliminating pain from injections and related procedures.

BRIEF SUMMARY OF THE INVENTION

Discussed herein are various embodiments relating to methods and devicesfor reducing or eliminating the pain from injections and other similarprocedures performed on skin by the application of vibrationstimulation, or alternatively by the application of a combination ofelectrical stimulation and vibration stimulation. More specifically, thevarious embodiments relate to an adhesive base and a coupleablestimulation module used to deliver vibration or both vibration andelectrical stimulation to the patient.

In Example 1, an apparatus for providing topical analgesia during aprocedure comprises a base, a vibration stimulation generating unitattachable to the base, and a flap hingedly coupled to the backinglayer. The base has a backing layer, an adhesive layer positionedagainst the backing layer, and at least one access area defined by thebase. The vibration stimulation generating unit is configured totransmit vibration energy to the base. The flap is configured to movebetween an open position and a closed position wherein the flap isdisposed over the at least one access area.

Example 2 relates to the apparatus according to Example 1 and furthercomprising a controller operably coupled to the vibration stimulationgenerating unit, the controller configured to control the vibrationstimulation generating unit.

Example 3 relates to the apparatus according to Example 2 and furthercomprising an input component operably coupled to the controller, theinput component configured to allow a user to input a control signal tocontrol intensity and duration of the vibration energy.

Example 4 relates to the apparatus according to Example 2, wherein thecontroller is further configured to initially gradually increase thevibration energy, generate randomly timed bursts of the vibrationenergy, automatically turn the apparatus on when the base and thevibration stimulation generating unit are coupled, and automaticallyshut off the apparatus when not in use.

Example 5 relates to the apparatus according to Example 1 and furthercomprising an attachment structure attachedly disposed between thevibration stimulation generating unit and the base, the attachmentstructure comprising one or more of ferromagnetic/electricallyconductive discs, conductive buttons, conductive leads, conductive tabs,conductive hooks, conductive snaps, conductive adhesive, and hook andloop fastener, wherein the attachment structure is configured to allowtransmission of vibration from the module to the base.

Example 6 relates to the apparatus according to Example 1, wherein theat least one access area is an orifice defined in the base, wherein theorifice has a circular, rectangular, or oval shape.

Example 7 relates to the apparatus according to Example 1, wherein theat least one access area is a notch.

Example 8 relates to the apparatus according to Example 1, wherein theat least one access area is an access area defined by an outer portionof the base.

Example 9 relates to the apparatus according to Example 1, wherein thevibration stimulation generating unit further comprises a displayconfigured to display at least one of a status of the controller,battery status, operation of the vibration stimuli, and patientphysiology.

Example 10 relates to the apparatus according to Example 1, wherein thevibration stimulation generating unit further comprises at least one ofa light display and a sound generator, wherein the light display and thesound generator are configured to distract the patient during theprocedure.

In Example 11, an apparatus for providing topical analgesia during aprocedure comprises a base, a stimulation module attachable to the base,a controller operably coupled to the stimulation module, an inputcomponent operably coupled to the controller, and a flap hingedlycoupled to the backing layer. The base, has a backing layer, an adhesivelayer positioned against the backing layer, and at least one access areadefined by the base. The stimulation module is configured to transmitenergy to the base, wherein the stimulation module comprises a vibrationstimulation generating unit configured to transmit vibration energy tothe base. The controller is configured to control the stimulationmodule, and the input component is configured to allow a user to input acontrol signal to control intensity and duration of the energytransmitted to the base. The flap is configured to move between an openposition and a closed position wherein the flap is disposed over the atleast one access area.

Example 12 relates to the apparatus according to Example 11, wherein thestimulation module further comprises a display configured to display atleast one of a status of the controller, battery status, operation ofthe stimulation module, and patient physiology.

Example 13 relates to the apparatus according to Example 11, wherein thestimulation module further comprises at least one of a light display anda sound generator, wherein the light display and the sound generator areconfigured to distract the patient during the procedure.

Example 14 relates to the apparatus according to Example 11, wherein thestimulation module further comprises an electrical stimulationgenerating unit configured to transmit electrical energy to the base,wherein the base further comprises an electrode.

In Example 15, an method for providing topical analgesia during aprocedure comprises attaching a base to a patient's skin, attaching amodule to the base, and generating, using the module, vibration energyin order to deliver a vibration stimuli through the electrode to thepatient's skin to provide an analgesic effect. The base has at least oneaccess area for allowing objects to pass through the at least one accessarea and into the patient's skin.

Example 16 relates to the apparatus according to Example 15 and furthercomprises the step of flipping down a flap hinged to the base over theat least one access point to act as a bandage dressing after theprocedure is completed, wherein the base and flap remain on the patientto act as a bandage.

Example 17 relates to the apparatus according to Example 15 and furthercomprises the steps of inputting a control signal to the module tocontrol the intensity and duration of the vibration energy, andcontrolling intensity and duration of the vibration energy using acontroller in the module.

Example 18 relates to the apparatus according to Example 15 and furthercomprises the step of displaying on a display, at least one or more ofthe status of the controller, battery status, operation of the moduleand patient physiology.

Example 19 relates to the apparatus according to Example 15 and furthercomprises the step of generating one or more of a light display andsounds, for distracting the patient during the procedure.

Example 20 relates to the apparatus according to Example 15 furthercomprises generating, using the module, electrical energy in order todeliver an electrical stimuli through the base to the patient's skin toprovide an analgesic effect, wherein the base comprises an electrode.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device for reducing or eliminating thepain associated with an injection or other similar procedure, accordingto one embodiment.

FIG. 2 is a bottom view of the embodiment of FIG. 1.

FIG. 3 is a top view of the embodiment of FIG. 1.

FIG. 4 is a side view of the embodiment of FIG. 1.

FIG. 5 is a magnified side view of the embodiment of FIG. 1.

FIG. 6 is a bottom view of a device for reducing or eliminating the painassociated with an injection or other similar procedure, according toanother embodiment.

FIG. 7 is a bottom view of a device for reducing or eliminating the painassociated with an injection or other similar procedure, according to afurther embodiment.

FIG. 8 is a bottom view of a device for reducing or eliminating the painassociated with an injection or other similar procedure, according toyet another embodiment.

FIG. 9 is a bottom view of a device for reducing or eliminating the painassociated with an injection or other similar procedure, according to afurther embodiment.

FIG. 10 is a bottom view of a device for reducing or eliminating thepain associated with an injection or other similar procedure, accordingto another embodiment.

FIG. 11A is a perspective view of a device for reducing or eliminatingthe pain associated with an injection or other similar procedure,according to yet another embodiment.

FIG. 11B is a top view of the embodiment of FIG. 11A.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1-5, one embodiment relates to an electrode 10comprising a non-conductive flexible backing 20 with two electricallyconductive surfaces 30 a and 30 b mounted onto this backing andpositioned close to each other at roughly opposing ends of theelectrode. Conductive skin adhesive 40 a and 40 b of the type commonlyfound on commercially available electrodes are positioned over eachconductive surface. The conductive surfaces and the conductive adhesiveoverlying these surfaces are separated from each other by a small space50 or a strip of non-conductive material so that the surfaces remainelectrically insulated from one another.

Each conductive surface and their associated conductive adhesive may beelectrically continuous with a means of connecting the electrode to theTENS/vibration unit 15. The method of connection may be viaferromagnetic/electrically conductive discs, conductive buttons,conductive snaps, conductive adhesive, hook and loop fastener, or otherconnective means 100 which may allow the transmission of both TENS andvibration stimulation to the electrode. Within or between the conductivesurfaces is a window 70 or orifice large enough to allow needles andsimilar sharp instruments to pass through the electrode and into theskin layer underneath. The selection of materials may be similar toconventional electrodes and are well known to those skilled in the artof electrode construction.

Referring to FIG. 1, The TENS/vibration unit 15 is a separate electronicdevice, which is designed to attach to the electrode via variouspossible connective means, which may allow the transmission of both TENSand vibration stimulation to the electrode. Enclosed within the compactergonomic casing is circuitry typical to that found in commerciallyavailable TENS generating units. This circuitry may have the ability togenerate single or multiple frequency TENS stimuli and deliver thiscurrent to the electrode in parallel or in series. Variables such asfrequency, current intensity, pulse width, and the like, may be madeuser adjustable.

Optionally included within the casing 15 is a means of creating thevibration stimuli. This may be accomplished by various means usingrotational or oscillating vibration devices commonly found in cellphones and pagers, for example. One or more of these vibration devicesmay be placed in the unit depending on the application. Programmablemicro controller circuitry similar to that found in many commerciallyavailable digital devices may also be enclosed within the unit tocontrol the TENS and vibration stimuli. It may be pre-programmed togradually increase both stimuli over a few seconds to a preset maximumlevel to prevent the initial sensation of surprise associated with amore sudden application of full electrical and TENS stimulation.

This micro controller may also be pre-programmed to deliver randomlytimed bursts of electrical and/or vibration stimuli causing another formof distraction for the patient and making it more difficult to identifywhen the injection actually occurs. The micro controller may beprogrammed to deliver varying levels of TENS stimuli based on user inputvia small buttons 155 on the unit. For example, the user may be asked topress one button for low, medium or high intensity prior to applicationof the unit in order to deliver appropriate amounts of current tovarious age groups with differing sensitivity levels. Suitable membraneswitches may be used to select the intensity and duration of electricaland vibration effect.

Alternately, wire, radio frequency (RF) or infrared control links may beused to provide a remote control so that the operator need not pressdirectly onto the TENS/vibration unit. LEDs, or an LED display, videodisplay or the like 156 may be used to indicate that the unit isoperating, the batteries are charged or discharged, and also show theamount of electrical and vibration stimuli, and other data. This microcontroller circuit may also be programmed to measure physiologicalvariables via the electrode contacts such as resistance or capacitanceof each individual's skin. These variables may be displayed on thedisplay of the unit, or may be transmitted to other apparatus via datalinks (wired, RF, Infrared, or the like) so as to record patient data ifrequired. Based on these brief initial readings, the micro controllermay then deliver an appropriate amount of TENS or vibration stimulation.

The micro controller circuitry may also be used to identify differenttypes of electrodes being used and then deliver a specific amount ofstimuli based on that initial identification. For example, if the unitis connected onto a child type electrode, the unit may identify thespecific electrode type via electrical or mechanical means unique to theelectrode type and then deliver the correct amount of stimuli. The microcontroller may also be pre-programmed so that the TENS and vibrationstimuli begin once the unit is firmly attached to the electrode and stopwhen the unit is pulled away. This may eliminate the extra step ofhaving to turn the unit on and off with every use. To power the entireunit, a small possibly rechargeable battery may also be enclosed within.

The embodiment described above is meant to reduce the pain experiencedwhen needles and similar devices are inserted into skin. This uniqueelectrode and TENS/vibration unit may be highly beneficial inalleviating pain due to immunizations, medication administration,phlebotomy, blood glucose checks, IV catheter placement, and the like.With minor changes in size and shape, this embodiment may be utilizedfor numerous other procedures as well.

In alternative embodiments, electrodes with the same basic features asdescribed herein may be shaped and sized to fit over specific bodystructures such as earlobes and fingers. The access window size and orshape may also be designed to accommodate different uses. Because ofthis, other medical applications may also benefit from this deviceincluding painful skin treatments such as laser therapy, skin biopsy,wart removal, splinter and hook removal, or any potentially painfulprocedure done at or near the skin surface. Of course the veterinaryfield may also benefit from the topical analgesic effects found usefulin human subjects. The use of this device is not limited to medicalprocedures. Painful cosmetic procedures such as ear and body piercing,tattooing, and hair removal may also be made more comfortable withvarious embodiments disclosed herein or similar thereto.

Commercially available electrodes have one conductive surface that maydeliver only one circuit of electrical stimulation. Studies in the pasthave suggested that multiple specific electrical impulse frequencies mayact to attenuate pain. See, e.g., Sluka K A, Walsh D., Transcutaneouselectrical nerve stimulation: basic science mechanisms and clinicaleffectiveness, J Pain. 2003 Apr;4(3):109-21, incorporated herein byreference.

Thus, it may be beneficial if a TENS electrode may deliver electricalstimulation of multiple different frequencies at the same time.Referring to FIG. 6, another embodiment may have four conductivesurfaces on one electrode 80 a, 80 b, 80 c, and 80 d surrounding anaccess window 70 which may allow simplified, concentrated, simultaneousapplication of multiple frequency electrical stimulation. Electricalstimulation of differing frequencies may also be delivered via twoisolated conductive surfaces as in FIG. 2 and FIGS. 7 through 10.

Referring now to FIG. 7, window 70 between the conductive surfaces 40 aand 40 b may also be in the shape of an elongated rectangle, oval, orother similar shape to allow TENS to be used as a topical analgesic forsmall laceration repairs or for IV catheter placement.

Referring to FIG. 8, a notch 90, instead of a window may also be used toallow for more visualization of the skin area between conductivesurfaces 40 a and 40 b.

Referring now to FIG. 9, the separate electrode conductive surfaces inthe various embodiments contemplated herein may be arranged side by sideas described above, in a concentric circular pattern around the accesswindow 70, or any pattern that allows for the electrical isolationbetween the two conductive surfaces 40 a and 40 b. Referring to FIG. 10,the electrode may also be made with multiple windows 70 within orbetween the conductive surfaces 40 a and 40 b to allow for multipleinjections such as those needed with immunizations or allergy testing.

Referring back to FIGS. 1 and 3, after a needle pierces the skin withinthe access window, an adhesive bandage flap with a gauze center 110 maybe designed to flip down onto the skin within the window 70 to protectthe site once the procedure is done. This may make it unnecessary toremove the electrode after a procedure in order to place a conventionalbandage. The electrode serves as a bandage for the patient to helpreduce bleeding, prevent infection, and aid in the healing process.

To help gain acceptance of the device by pediatric patients and to actas another form of visual distraction, the non-conductive backing of theelectrode and/or the attached TENS/vibration unit may be printed withcolors and/or shaped to resemble animals, cartoon characters, and thelike. Small colorful LEDs or other light sources having low power drainmay also be placed on the electrode and/or TENS/vibration unit to offeryet another interesting distraction. A flat panel display, for example,may provide information about the operation of the device and alsogenerate a distracting pattern or image so the patient is distractedfrom the procedure.

Similarly, circuitry may be included within the electrode and/or theattached TENS/vibration unit to emit sounds, music, spoken words, andthe like, meant to serve as an auditory distraction. Licensed charactersmay present audio messages, for example, to encourage and distractchildren during the procedure. After the procedure, the patient may beencouraged to keep the electrode as a type of reward or “sticker” forgetting his/her “shots” that day, and the electrode may serve as bandageas well. Licensed characters or other designs may appear on theelectrode and/or TENS/vibration unit for decorative or amusementpurposes.

A smaller electrode similar to the embodiments described above may alsobe employed to provide nerve block to the fingers. The electrode may bewrapped around the base of a finger with the conductive surfacesoverlying the nerves on either side of the finger. This placement mayprovide analgesia over an entire digit, resulting in decreased pain fromblood sugar testing, laceration repairs, and other similar procedures.It is understood that the electrodes of the various embodimentsdisclosed herein may be made in other sizes and shapes without departingfrom the spirit and scope of the present invention, for otherapplications and operations.

Another embodiment of a device 200 for reducing or eliminating the painfrom an injection or other similar procedure is depicted in FIGS. 11Aand 11B. The device 200 has a base 200 (also referred to as a “patch”)to which a stimulation unit 202 can be coupled. The base 200 has a first(or “top”) layer 204, along with a second (or “bottom” or “underside”)layer (not shown). According to one embodiment, the top layer 204 is aflexible layer that can also be referred to as a “backing” 204. The toplayer can be made of flexible plastic, flexible cardboard, or any otherknown material commonly used in the backing of commercially availabledisposable bandages and similar medical products. The bottom layer, inone implementation, is an adhesive layer that can be placed in contactwith a patient's skin to adhere the base 200 to the skin. The bottomlayer can be made of any known material commonly used in the adhesivelayer of commercially available disposable bandages and similar medicalproducts.

In one embodiment, the base 200 is coupled to the stimulation unit 202at the two connectors 210 on the base 200. Alternatively, the base 200can have one connector, or more than two. It is understood that anyknown connector or coupling component can be used to coupled thestimulation unit 202 to the base 200 so long as the connector allows fortransfer of the stimulation energy from the stimulation unit 202 to thebase 200.

The base 200 also has an opening 206 defined in the base 200. Theopening 206 as shown is an orifice 206 defined by the base 200.Alternatively, the opening 206 can take any shape in the base 200.Further, the opening 206 can be defined along an outer portion of thecircumference of the base 200 such that the opening 206 is onlypartially defined by the base 200. It is further understood that theopening 206 can take any shape as contemplated above as depicted inFIGS. 7, 8, 9, and 10. It is understood that the opening 206 is largeenough to allow needles and similar sharp instruments to pass throughthe base 200 and into the skin layer underneath.

According to various alternative embodiments, the base 200 can also havea cover or flap 208 that is hingedly coupled to the base 200 andpositioned at or near the opening 206 such that the cover 208 can bemoved between an open position and a closed position in which it coversthe opening 206. According to one embodiment, the flap 208 has at leastsome adhesive on the surface that is configured to contact the base 200in the closed position, thereby adhering the flap 208 to the base 200.In a further embodiment, the flap 208 can also have a gauze center. Inone implementation, the closed position can protect the injection orinsertion site once the procedure is done. In use, after a needlepierces the skin within the opening 206, the flap 208 can be flippeddown onto the skin accessible through the opening 206 to protect thesite once the procedure is done. This may make it unnecessary to removethe base 200 after a procedure in order to place a conventional bandage.The base 200 serves as a bandage for the patient to help reducebleeding, prevent infection, and aid in the healing process.

According to one embodiment, the stimulation unit 202 is a separatedevice, which is designed to attach to the electrode via variouspossible connective means (as described above) and is configured totransmit either TENS or vibration stimulation or both to the base 200and thus to the skin of the patient.

In accordance with one implementation, the stimulation unit 202 has adevice configured to create the vibration stimuli. This may beaccomplished by various devices or components using rotational oroscillating vibration devices commonly found in cell phones and pagers,for example. One or more of these vibration devices may be placed in theunit 202 depending on the application. Programmable micro controllercircuitry similar to that found in many commercially available digitaldevices may also be enclosed within the unit to control the vibrationstimuli. It may be pre-programmed to gradually increase the stimuli overa few seconds to a preset maximum level to prevent the initial sensationof surprise associated with a more sudden application of full vibrationstimulation.

This micro controller, in one embodiment, may also be pre-programmed todeliver randomly timed bursts of vibration stimuli causing another formof distraction for the patient and making it more difficult to identifywhen the injection actually occurs. The micro controller may beprogrammed to deliver varying levels of vibration timuli based on userinput via small buttons 212 on the unit. For example, the user can pressone button for low, medium or high intensity prior to application of theunit in order to deliver appropriate amounts of vibration to various agegroups with differing sensitivity levels. Suitable membrane switches maybe used to select the intensity and duration of vibration effect.

Alternately, wire, radio frequency (RF) or infrared control links may beused to provide a remote control so that the operator need not pressdirectly onto the vibration unit. LEDs, or an LED display, video displayor the like 214 may be used to indicate that the unit is operating, thebatteries are charged or discharged, and also show the amount ofvibration stimuli, and other data.

The micro controller may also be pre-programmed so that the vibrationstimuli begins once the unit 202 is firmly attached to the base 200 andstop when the unit 202 is pulled away. This may eliminate the extra stepof having to turn the unit 202 on and off with every use. To power theentire unit 202, a small possibly rechargeable battery may also beenclosed within.

It is understood that, in the embodiments of the device shown in FIGS.11A and 11B in which the stimulation device 202 transmits TENS (or bothTENS and vibration), the base 200 is an electrode having any of thecharacteristics, structures, or features described with respect to thevarious other embodiments described above, and the stimulation unit 202can have micro controller circuitry that is configured to control theTENS stimulation in the same fashion as described with respect to thevarious other embodiments described above.

The various embodiments described above relating to FIGS. 11A and 11Bare meant to reduce the pain experienced when needles and similardevices are inserted into skin. These unique base and vibration unitimplementations may be highly beneficial in alleviating pain due toimmunizations, medication administration, phlebotomy, blood glucosechecks, IV catheter placement, and the like. With minor changes in sizeand shape, these embodiments may be utilized for numerous otherprocedures as well.

Bases with the same basic features as described above may be shaped andsized to fit over specific body structures such as earlobes and fingers.The opening size and or shape may also be designed to accommodatedifferent uses. Because of this, other medical applications may alsobenefit from this device including painful skin treatments such as lasertherapy, skin biopsy, wart removal, splinter and hook removal, or anypotentially painful procedure done at or near the skin surface. Ofcourse the veterinary field may also benefit from the topical analgesiceffects found useful in human subjects. The use of the variousembodiments disclosed herein is not limited to medical procedures.Painful cosmetic procedures such as ear and body piercing, tattooing,and hair removal may also be made more comfortable with these devicesand methods.

Like the other implementations described above, the backing of the base200 and/or the attached stimulation unit 202 may be printed with colorsand/or shaped to resemble animals, cartoon characters, and the like.Small colorful LEDs or other light sources having low power drain mayalso be placed on the base 200 and/or stimulation unit 202 to offer yetanother interesting distraction. A flat panel display, for example, mayprovide information about the operation of the device and also generatea distracting pattern or image so the patient is distracted from theprocedure.

Similarly, circuitry may be included within the base 200 and/or theattached stimulation unit 202 to emit sounds, music, spoken words, andthe like, meant to serve as an auditory distraction. Licensed charactersmay present audio messages, for example, to encourage and distractchildren during the procedure. After the procedure, the patient may beencouraged to keep the base 200 as a type of reward or “sticker” forgetting his/her “shots” that day, and the base 200 may serve as bandageas well. Licensed characters or other designs may appear on the base 200and/or stimulation unit 202 for decorative or amusement purposes.

A smaller base similar to the invention described above may also beemployed to provide nerve block to the fingers. The base may be wrappedaround the base of a finger. This placement may provide analgesia overan entire digit, resulting in decreased pain from blood sugar testing,laceration repairs, and other similar procedures. It is understood thatthe various embodiments of the base disclosed herein may be made inother sizes and shapes without departing from the spirit and scope ofthe present invention, for other applications and operations.

Although the present invention has been described with reference topreferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A method for providing topical analgesia during aprocedure, the method comprising: contacting a base to a patient's skin,the base having at least one access area configured to allow objects topass through the at least one access area and into the patient's skin;coupling a stimulation module to the base such that the stimulationmodule is removable from the base, the stimulation module comprising avibration stimulation generating unit; measuring, with the base, atleast one physiological variable of the patient's skin and transmittingmeasurements relating to the at least one physiological variable to acontroller in the stimulation module; and generating, with the vibrationstimulation generating unit, vibration energy based on the measurementsrelating to the at least one physiological variable and thereby delivervibration stimuli through the base to the patient's skin to provide ananalgesic effect.
 2. The method of claim 1, wherein the stimulationmodule further comprises an electrical stimulation generating unit, themethod further comprising generating, with the electrical stimulationgenerating unit, electrical energy and thereby deliver electricalstimuli through the base to the patient's skin to provide an additionalanalgesic effect.
 3. The method of claim 2, further comprising the stepsof: inputting a control signal to the module to control the intensityand duration of the electrical stimuli and vibration stimuli; andcontrolling intensity and duration of the electrical stimuli andvibration stimuli using the controller in the module.
 4. The method ofclaim 1, wherein the base further comprises: a backing layer; and anadhesive layer positioned against the backing layer, the adhesive layerbeing configured to be adherable to a patient's skin.
 5. The method ofclaim 1, wherein the step of coupling the module to the base furthercomprises the step of attaching the module to the base using one or moreof ferromagnetic/electrically conductive discs, conductive buttons,conductive leads, conductive tabs, conductive hooks, conductive snaps,conductive adhesive, and hook and loop fastener to allow transmission ofthe vibration energy.
 6. The method of claim 1, further comprisingremoving the module from the base and disposing of the base.
 7. Themethod of claim 1, further comprising the steps of: inputting a controlsignal to the module to control the intensity and duration of thevibration stimuli; and controlling intensity and duration of thevibration stimuli using the controller in the module.
 8. The method ofclaim 7, further comprising initially ramping up the vibration stimuliusing the controller, to avoid surprising the patient.
 9. The method ofclaim 7, further comprising automatically generating, using the module,vibration energy when connected to the base and automaticallydiscontinuing generation of vibration energy when not in use.
 10. Asystem for providing topical analgesia during a procedure, the systemcomprising: (a) a base comprising: (i) a backing layer; (ii) an adhesivelayer positioned against the backing layer, the adhesive layer beingconfigured to be adherable to a patient's skin; and (iii) at least oneaccess area defined by the base, the at least one access area configuredto allow at least one object to pass through the access area andpenetrate the patient's skin, wherein the base is configured to measureat least one physiological variable of the patient's skin; (b) a moduleremovably coupleable to the base, the module configured to: (i) receivefrom the base measurements relating to the at least one physiologicalvariable; and (ii) generate vibration energy based on the measurementsin order to deliver vibration stimuli through the base and to thepatient's skin to provide an analgesic effect, wherein the vibrationstimuli act to mask pain signals caused when the at least one objectpenetrates the patient's skin.
 11. The system of claim 10, wherein themodule is further configured to generate electrical energy to deliverelectrical stimuli through the base to the patient's skin to provide anadditional analgesic effect.
 12. The system of claim 11, wherein themodule comprises: a controller configured to control intensity, timing,and duration of the vibration stimuli and the electrical stimuli; and aninput component configured to allow for inputting a control signal tocontrol the intensity, timing, and duration of the vibration stimuli andthe electrical stimuli.
 13. The system of claim 10, further comprising acoupling component configured to removably couple the module to thebase, the coupling component comprising one or more offerromagnetic/electrically conductive discs, conductive buttons,conductive leads, conductive tabs, conductive hooks, conductive snaps,conductive adhesive, or hook and loop fastener to allow transmission ofthe vibration energy.
 14. The system of claim 10, wherein the modulecomprises: a controller configured to control intensity, timing, andduration of the vibration stimuli; and an input component configured toallow for inputting a control signal to control the intensity, timing,and duration of the vibration stimuli.
 15. The system of claim 14,wherein the controller is configured to initially ramp up the vibrationstimuli to avoid surprising the patient.
 16. The system of claim 14,wherein the controller is configured to automatically actuate the moduleto generate the vibration energy when connected to the base andautomatically actuate the module to discontinue generation of thevibration energy when not in use.